Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

Insomnia Clinical Trial

Official title:

The Impact of Gastroesophageal Reflux Disease in Sleep Disorders: A Pilot Investigation of Rabeprazole, 20 mg Twice Daily for the Relief of GERD-Related Insomnia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287391
• Other study ID #: SLEEP
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2006
• Last updated: April 25, 2007
• Start date: September 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep disturbance. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. Even very small, unnoticeable amounts of rising stomach acid may cause patients to wake up during the night.

This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients with known insomnia. Rabeprazole is an FDA approved medication already marketed for the treatment of GERD.

Description:

Participants with known insomnia will undergo an overnight pH and sleep study. Those found to be eligible after the first sleep study (those with significantly poor sleep quality and no significant sleep apnea) will be started on 2 weeks 20 mgs, twice-a-day, rabeprazole. Upon completion of the 2 week course of rabeprazole, subjects will repeat the overnight pH and sleep studies. Upon completion of these studies, participation is complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. English-speaking male or female subjects, 18-75 years of age. (Women must be two (2) years post-menopausal or surgically sterile. Women of childbearing potential or <1 year post-menopausal must be practicing an approved method of contraception and have a negative urine pregnancy test at screening.),

2. a six-month duration of insomnia,

3. sleep difficulty at least 3 nights per week, and a sleep study demonstrating > 10 arousals/hour for those aged < 45, and >15 for those who are 45 or older.

Exclusion Criteria:

1. BMI > 30 or history of snoring (in order to decrease the prevalence of sleep apnea in the sample),

2. use of any proton pump inhibitor or H2 receptor antagonist within one week of undergoing initial sleep study,

3. previous acid-suppressing medication for sleep disturbances,

4. previous surgical antireflux procedure,

5. current medical therapy that includes digoxin or ketoconazole,

6. previous aerodigestive malignancy,

7. a previously diagnosed psychological or medical cause of insomnia (other than suspected GERD), and

8. inability or unwillingness to provide consent for the procedures.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD
• Insomnia
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• Rabeprazole

Locations

Country	Name	City	State
United States	UNC Gastroenterology and UNC Sleep Disorders Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina	Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of: subjects with non-OSA sleep disturbances who demonstrate esophageal reflux, night-time arousals which are accompanied by a reflux event.